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临床试验/NCT04189003
NCT04189003已完成不适用

Identification of Specific Molecular Signatures by Capture-HPV and Next-generation Sequencing in HPV-induced Oropharyngeal Cancers

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2019年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
66
试验地点
1
主要终点
Description the HPV molecular signatures identified by the Capture-HPV technique and comparison of these signatures with those already described in the classification described in the Holmes et al. in the cervix

研究概览

简要总结

The aim of this study is to identify HPV molecular signature in head and neck cancer to establish a new classification for positive human papillomavirus oropharyngeal tumor

详细描述

OROPAP is a monocentric exploratory study with retrospective inclusion of patients.

The retrospective study focus on patients who have had surgery for HPV-positive oropharyngeal tumors whose survival is at least 2 year.

Frozen and or FFPE biopsies of these tumors and frozen blood samples are available via the HEGP biological resources platform.

The HPV molecular signatures will be identified by the capture-HPV technique.

For each patient, clinical-anatomo-pathological data such as tumor size, tumor stage, presence or absence of metastasis, histological stage, different treatment lines and 2-years survival data will be collected through the use of data warehouse available on the HEGP.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with HPV + oropharyngeal cancer

排除标准

  • 未提供

结局指标

主要结局

Description the HPV molecular signatures identified by the Capture-HPV technique and comparison of these signatures with those already described in the classification described in the Holmes et al. in the cervix

时间窗: 18 months

Establish a new classification based on HPV molecular signature for positive human papillomavirus oropharyngeal tumor

次要结局

  • Correlate identified HPV molecular signature with clinical-anatomo-pathological data.(18 months)
  • Description of new HPV viral variants based on complete HPV genome sequencec obtained by Capture-HPV coupled with NGS(18 months)
  • Quantification of HPV circulating tumoral DNA in peripheral blood by droplet based digital PCR(18 months)
  • Number of Death of any cause, or eventual relapse(18 months)
  • Ratio of the number of copies of viral genes to the number of cells(18 months)
  • Precise description of HPV insertion localisation in human genome when HPV is integrated(18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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